Sotyktu

Sotyktu (deucravacitinib) is used to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, or to treat active psoriatic arthritis in adults. It is an oral tablet taken once a day.

• For plaque psoriasis, Sotyktu is not recommended in combination with other potent immunosuppressants.
• It helps improve scaling and redness and reduce thickened areas associated with plaque psoriasis, with some patients achieving clear or almost clear skin and scalp.
• In a clinical trial, 58% of Sotyktu patients had a 75% improvement in their psoriasis score after 16 weeks, and 70% of patients had their scalp psoriasis clear or almost clear (clinical trial PSO-1 NCT03624127).
• Significantly more patients with psoriatic arthritis treated with once-daily, oral Sotyktu achieved an ACR20 response compared with placebo at Week 16 in the pivotal Phase 3 POETYK PsA-1 and POETYK PsA-2 clinical trials.

Sotyktu (deucravacitinib) works by targeting TYK2, a protein that drives the inflammation behind plaque psoriasis and psoriatic arthritis. By blocking TYK2, it calms the overactive immune response responsible for these conditions. Sotyktu belongs to the drug class called TYK2 inhibitors.

Sotyktu received FDA approval on September 9, 2022, for plaque psoriasis. Approval was extended on March 6, 2026, to include psoriatic arthritis.

Take the Sotyktu tablet once daily with or without food. Do not crush, cut, or chew the tablets.

Take the Sotyktu tablets exactly as directed by your healthcare provider.

Infections

This medicine affects your immune system and can make you more likely to get infections or worsen any infections you may have. Some people have had serious infections while taking Sotyktu, such as infections of the lungs, including pneumonia, tuberculosis (TB), and COVID-19.

• Your healthcare provider should check you for infections and TB before starting treatment.
• Your healthcare provider may treat you for TB before you begin treatment if you have a history of TB or have active TB.
• Your healthcare provider should watch you closely for signs and symptoms of TB during treatment.
• If you get a serious infection, your healthcare provider may tell you to stop treatment until your infection is controlled.

Sotyktu should not be used in people with an active, serious infection, including localized infections. You should not start taking Sotyktu if you have any kind of infection unless your healthcare provider tells you it is okay.

After you start taking Sotyktu, call your healthcare provider right away if you have an infection or have symptoms of an infection.

You may be at a higher risk of developing shingles (herpes zoster).

Cancer

Certain kinds of cancer, including lymphoma, have been reported in people taking Sotyktu. Tell your healthcare provider if you have ever had any type of cancer.

You should not use this medicine if you are allergic to the active ingredient deucravacitinib, or any inactive ingredients.

Tell your doctor if you have ever had:

• liver or kidney disease
• hepatitis B or heptatitis C
• high blood levels of fat (triglycerides)
• any type of cancer
• tuberculosis or have been exposed to tuberculosis
• if you have an infection that keeps returning or does not go away
• If you think you have an infection, are being treated for an infection or have symptoms of an infection such as fever, sweats, or chills, muscle aches, weight loss, cough, shortness of breath, blood in your phlegm (mucus), warm, red, or painful skin or sores on your body different from your psoriasis, diarrhea or stomach pain, burning when you urinate or urinating more often than normal, feeling very tired
• if you have recently received or are scheduled to receive a vaccine; or
• if you have high blood pressure, high cholesterol, diabetes, menopause (women), family history of coronary artery disease, being overweight, or being over 50, or if you smoke.

Sotyktu is not recommended for use in combination with other potent immunosuppressants.

Pregnancy

It is not known if deucravacitinib can harm your unborn baby. Report pregnancies to the Bristol-Myers Squibb Company’s Adverse Event reporting line at 1-800-721-5072.

Breastfeeding

It is not known if deucravacitinib passes into breast milk.

Common Sotyktu Side Effects

The common Sotyktu side effects are acne, cold symptoms (stuffy nose, sneezing, sore throat), cold sores, sores on your gums, tongue, or mouth, hair follicle infection, or inflammation (folliculitis). These side effects occurred in 1% or more of patients in clinical trials.

Serious Sotyktu Side Effects

Sotyktu can cause serious side effects, including:

Rhabdomyolysis. The breakdown of muscle tissue (rhabdomyolysis) can lead to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have fever, unusual tiredness, or dark urine.

Infection. Call your doctor at once if you have signs of infection, including fever, chills, muscle pain, shortness of breath, weight loss, diarrhea or stomach pain, burning when you urinate, feeling very tired, skin warmth or redness, painful skin sores, or coughing up blood.

Allergic reactions: Get emergency medical help if you have signs of an allergic reaction, including hives, difficulty breathing, and swelling of your face, lips, tongue, or throat.

Changes in laboratory tests have happened in some people taking Sotyktu. Your healthcare provider may do blood tests before you start and during treatment to check for increased triglycerides and increased liver enzymes.

Potential risks from Janus kinase (JAK) inhibition. Sotyktu is a tyrosine kinase 2 (TYK2) inhibitor. TYK2 is in the JAK family. It is not known whether taking Sotyktu has the same risks as taking JAK inhibitors. Increased risk of death (all causes) has happened in people who were 50 years of age and older with at least one heart disease (cardiovascular) risk factor who were taking a JAK inhibitor used to treat rheumatoid arthritis (RA) compared to people taking another medicine in a class of medicines called TNF blockers. Sotyktu is not for use in people with rheumatoid arthritis. Low blood sugar (hypoglycemia) in people with diabetes has happened after taking JAK inhibitors. Tell your healthcare provider if you have any problems with low blood sugar.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Sotyktu Dose for Plaque Psoriasis or Psoriatic Arthritis

• 6 mg orally once daily.
• Take with or without food.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Sotytku is not recommended for use in combination with other potent immunosuppressants.

• Store at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep all medicines out of the reach of children and pets.

Sotyktu Active ingredient: deucravacitinib.Sotyktu Inactive ingredients: anhydrous lactose, croscarmellose sodium, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose and silicon dioxide.Film coating Opadry® II Pink: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide red and yellow.

Sotyktu Bristol-Myers Squibb Company, Princeton, New Jersey 08543 USA